Kornimate/medical-research-clean huggingface dataset:
a phase ii study of imiquimod 5 % cream for the treatment of hemangioma in infancy

Conditions: Hemangioma, Capillary

Summary: hemangiomas of infancy, the most common benign tumors of infancy, are congenital or early infancy lesions characterized by a rapid postnatal growth, with high expression of angiogenic stimulators for 9-18 months, followed by slow regression for 5-9 years. current therapies for the hemangiomas are usually restricted to more severe forms due to the risks of adverse effects, inconvenience and cost. nevertheless, a substantial amount of the psychological discomfort and morbidity can be caused by untreated hemangiomas, especially those in the face. recently, imiquimod 5% cream has emerged as a safe an effective drug for several skin conditions that benefit from modulation of the activity of the immune system, such as common warts and various forms of the skin pre-cancerous and cancerous lesions. small case reports series have suggest that it could also be useful in hemangiomas, possibly through the inhibition of the angiogenesis by local ifn production.this is a small, open label study of 16 patients to document the efficacy of the imiquimod 5% cream in the treatment of hemangioma of infancy (primary outcome). ifn and plasma drug levels, as well as clinical examinations and blood studies, will be carried out to evaluate safety of the treatment (secondary outcome). bfgf and vegf will be measured in blood and urine in order to study the diagnostic and predictive value of these pro-angiogenic factors in the response of hemangiomas to the treatment with imiquimod (secondary outcome). the study is a phase ii clinical trial of a once a day application of imiquimod 5% cream, 3 to 7 times per week for a maximum of four months. the study held at the dermatology clinic of sainte-justine hospital, and was completed within a 20 months timeframe after irb approval.


Eligibility criteria:
inclusion criteria: * healthy infants aged 2-12 months. * superficial or mixed hemangiomas in proliferative phase (growing in size in the last 1-2 months). * hemangiomas must be less than 10x10 cm and must not be ulcerated. exclusion criteria: * preterm infant (less than 36 weeks of gestation). * ulceration of hemangioma prior to treatment. * immunosuppression. * hemangioma located on the eyelid or perianal region. * prior treatment of the hemangioma. * concomitant diseases. * presence of multiple hemangiomas and/or hemangiomas that would require systemic drug treatment. * potential difficulties with follow-up (patient from another town,difficult access to the hospital , etc.). * history of allergy to any of the components of the drug preparation. * hemangiomas more than 10x 10 cm or ulcerated before the start of the treatment.

Keywords: infantile hemangioma hemangioma hemangioma of infancy benign tumors of infancy congenital hemangioma capillary
identification and characterization of the biomarker in synovial fluid for hyaluronic acid therapy in osteoarthritis

Conditions: Osteoarthritis

Summary: the purpose of this study is to use the proteomic analysis of synovial fluid to perform the comprehensive investigation of the biomarker that will be useful to assign the tratment effectiveness of five weekly intra-articular ha injection.

the intra-articular injection with ha is an accepted therapy for oa. however, the exact regulation of ha treatment is unclear. compared the expression sf proteome from oa patients who received ha/800 treatment or not (post and pre-ha treatment) may be possible to identify the protein that response to the ha treatment and apply this to prognosis of oa. we used two-dimensional difference gel electrophoresis (2d-dige) combined with matrix-assisted laser desorption ionization time of light mass spectrometry (maldi-tof) to determine the differentially displayed proteins in human sf. finally, we used western blotting and elisa analysis to validate the potential biomarkers.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of osteoarthritis * accept the intra-articular ha injection therapy exclusion criteria: -

Keywords: osteoarthritis synovial fluid hyaluronic acid
a trial of two daclizumab dosing strategies vs. no induction treatment with tacrolimus, mycophenolate mofetil , & steroids for the prevention of acute allograft rejection in simultaneous kidney/pancreas transplant recipients

Conditions: Acute Allograft Rejection in Simultaneous Kidney/Pancreas Transplant Recipients

Summary: the purpose of the study is to determine the safety and efficacy of two dosing regimens of daclizumab in simultaneous kidney/pancreas transplant recipients.

the purpose of the study is to determine the safety and efficacy of two dosing regimens of daclizumab as an adjunctive immunosuppressive agent in simultaneous kidney/pancreas transplant recipients receiving tacrolimus, mycophenolate mofetil, and steroids as primary maintenance immunosuppression.

Eligibility criteria:
inclusion criteria: * simultaneous kidney/pancreas transplant recipients * insulin dependent type 1 or 2 diabetes pretransplant * recipient age 18-65 years * donor age 5-65 years * women must have negative serum pregnancy test and practice birth control for study duration * negative t-cell crossmatch * parent (or guardian) is able to understand the consent form and give written informed consent exclusion criteria: * prior treatment with daclizumab * known sensitivity or contraindication to tacrolimus, mmf, or steroids * patient with significant or active infection * patients with a positive lymphocytotoxic crossmatch using donor lymphocytes and recipient serum * patients whose life expectancy is severely limited by diseases other than renal disease * ongoing substance abuse, drug or alcohol * major ongoing psychiatric illness or recent history of noncompliance * insufficient cardiovascular reserve * malignancy within last 5 years, excluding nonmelanoma skin cancers * serologic evidence of infection with hiv or hepatitis b surface antigen positive * investigational drug within 30 days prior to transplant surgery * anti-t cell therapy within 30 days prior to transplant surgery

Keywords: kidney transplant pancreas transplant daclizumab tacrolimus mycophenolate mofetil steroids immunosuppression acute allograft rejection
personalized cellular vaccine for brain metastases (percellvac3)

Conditions: Brain Cancer; Neoplasm Metastases

Summary: cancer patients with brain metastases (bm) have poor prognosis. current treatments produce limited efficacy. recent advance in cancer immunotherapy has provided important new means to treat cancer patients at advanced stages. this study is designed to perform a clinical trial to treat advanced caner patients with brain metastases with personalized dendritic cell-based cellular vaccines. the patients will receive vaccines consisting of mrna tumor antigen pulsed dcs. immune response to the immunized tumor antigens will be monitored. safety and efficacy will be observed in this study.

this is an open label, single-arm, single-institution, phase i study designed to investigate the safety and efficacy of personalized cellular tumor vaccines for cancer patients with brain metastases (bm). bm patients will undergo tumor resection or biopsy and the tumor tissues will be analyzed for the expression of tumor antigens and immune-related genes. the patients will be immunized with dcs pulsed with mrna encoded tumor antigens. patients will be immunized with dc vaccines on a biweekly basis. safety and efficacy will be monitored. the objective of this study is to assess the safety of the personalized cellular vaccines and to deterimine the antitumor specific t cell responses. the efficacy of the vaccines will be determined using rano-bm criteria, progression-free survival and overall survival.

Eligibility criteria:
inclusion criteria: * solid tumor with brain metastases. * patients at the age of 18-65. * patients undergo tumor resection or biopsy. * patients with karnofsky scores \> or =70 * patients with normal range of hematologic and metabolic test results. * patients must have no corticosteroids treatment at least one week before vaccination. * patients capable of understanding the study and signed informed consent. exclusion criteria: * infectious diseases hiv, hbv, hcv. * documented immunodeficiency. * documented autoimmune disease. * breast feeding females. * pregnant women. * any serious or uncontrolled medical or psychiatric conditions, for example, severe pulmonary, cardiac or other systemic disease. * patient inability to participate as determined by pi discretion.

Keywords: solid tumors brain metastases dc vaccine personalized vaccine tumor antigens
[c-11]nop-1a and alcohol use disorder

Conditions: Alcohol Use Disorder

Summary: the goal of this study is to compare \[c-11\]nop-1a binding in recently abstinent alcohol use disorders and controls

this will allow for understanding brain stress and antistress mechanisms that underlie abuse of alcohol in humans

Eligibility criteria:
\[a\] alcohol use disorders (aud) inclusion criteria: 1. males or females 2. fulfill dsm5 diagnosis for alcohol use disorder 3. medically healthy exclusion criteria: 1. pregnancy or lactation 2. comorbid severe/major medical, psychiatric (such as bipolar and psychotic disorders, etc.,) and current comorbid drug use disorders (other than tobacco use and recreational marijuana use) 3. metal implants or paramagnetic objects contained within the body which may interfere with mri scans 4. currently employed as a radiation worker, or participation in radiation drug research procedures within the previous year 5. currently on any psychotropic medications that can influence nociceptin transmission in the brain \[b\]healthy controls inclusion criteria: 1. males or females 2. absence of present or past psychiatric conditions (including alcohol or drug use disorders) 3. medically healthy exclusion criteria: 1. pregnancy of lactation 2. medical, psychiatric or comorbid drug/alcohol use disorders 3. metal implants or paramagnetic objects contained within the body which may interfere with the mri scan 4. currently employed as a radiation worker; or participation in radioactive drug research protocols within the previous year 5. currently on any psychotropic medications that can influence nociceptin transmission in the brain 6. family history of psychotic disorder, manic episode, drug and alcohol use disorder in first-degree relatives
serine proteases in gastrointestinal function and irritable bowel syndrome (ibs)

Conditions: Colon, Irritable

Summary: the proposed pilot project for this seed grant focuses on the role of intestinal serine-proteases in the pathogenesis of diarrhea-predominant ibs (d-ibs). in this study we will further assess serine-protease activity in patients with d-ibs and also explore a possible mechanism by which these proteases can lead to alterations in intestinal physiology and symptoms in these patients. the general hypotheses for the proposed research are that (a) the levels of fecal serine-protease in patients with d-ibs are abnormally increased (b) this abnormal serine-protease activity leads to/is associated with an abnormal increase in intestinal permeability and therefore enables (c) chronic stimulation and activation of the mucosal immune system in these patients. in addition, it is aim to determine whither periodontal inflammation is associated with intestinal permeability and serine protease activity.


Eligibility criteria:
inclusion criteria: * any sex, race, or ethnicity. * at least 18 years of age (no upper age limit). * d-ibs patients must meet rome iii criteria for ibs and must have been evaluated by a physician to exclude other diseases that could explain the symptoms. for the latter, patients self statement is acceptable (no official document is required). * participation in dr. whitehead's 'heterogeneity of ibs' and/or dr. ringel's 'intestinal inflammation in patients with d-ibs' research study. exclusion criteria: * healthy controls must have no significant or recurring gastrointestinal symptoms. * patients and healthy controls should not have a serious, unstable medical condition. * patients and healthy controls must have had no gastrointestinal tract surgery other than appendectomy or cholecystectomy. * patients and healthy controls must not be pregnant (by self-report). pregnant women will not be allowed to participate as pregnancy can affect gastrointestinal symptoms. * patients and healthy controls must not have a history of inflammatory bowel disease, celiac disease, or other diagnosis that could explain chronic or recurring bowel symptoms in ibs patients or controls. * patients and healthy controls should have no history of lactose malabsorption (by self-report). * patients and healthy controls should have no history of clinical symptoms of acute infections during the last 8 weeks prior to enrolment in the study. * patients and healthy controls should have no history of anti-inflammatory agents including aspirin, non-aspirin, non-steroid anti-inflammatory (nsaid) or steroids in the last four weeks prior to study enrollment. * patients should not intentionally consume probiotics or undergo antibiotic treatment during the last 4 weeks prior to enrolment in the study. if the subject consumed any of these medications, a washout period of 4 weeks will be required). * patients must have no history of fainting or light headedness during periods of fasting. * patients must not have diabetes mellitus, or any similar conditions, that would cause an adverse reaction to the sugar drink.

Keywords: colon, irritable microbiota
the pharmacokinetics, safety and tolerability of in-c009 in healthy subjects

Conditions: Diabetes Mellitus

Summary: this study was conducted as a randomized, open-label, single-dose, crossover study design. all participants were randomly allocated for group a (period 1: individual components (ics), period 2: fcdp) and group b (period 1: fcdp, period 2: ics), and each group was administered either a single dose of in-c009 (fcdp, dapagliflozin 10mg/linagliptin 5 mg) (hk inno.n., seoul, korea) or co-administration of a single dose of dapagliflozin (forxiga 10 mg, astrazeneca, cambridge, england, uk) and linagliptin (trajenta 5mg, beringer-ingelheim, ingelheim, germany) after at least 10 hours of overnight fasting. after the 28 days of the washout period, the participants received the opposite treatment (group a: in-c009; group b: dapagliflozin and linagliptin). the dosage of dapagliflozin and linagliptin in the study is commercially used and recommended amount for the control of t2dm currently. on the day 1 (the day of each drug administration), the serial blood samples were drawn immediately before (0 h) and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, and 72 h (for dapagliflozin), and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, and 72 h (for linagliptin) after the each dosing to assess pharmacokinetics of each drugs.


Eligibility criteria:
inclusion criteria: * age between 19 to 45 years; * body weight more than 50 kg exclusion criteria: * a history or evidence of hepatic, renal, gastrointestinal, or hematological abnormality; * hepatitis b, hepatitis c, syphilis, or hiv infection; * a history of hypersensitivity to dapagliflozin and/or linagliptin; * clinically significant allergic disease; alcohol or drug abuse; * heavy smoker (more than ten cigarettes per day); * use of any medication within 30 days before the start of the study that may affect the study results.
freedom dr: oral treprostinil in combination with an endothelin receptor antagonist (era) and/or a phosphodiesterase-5 (pde-5) inhibitor or as monotherapy for the treatment of pulmonary arterial hypertension (pah)

Conditions: Pulmonary Hypertension

Summary: this study is an international, multi-center, randomized, double-blind, placebo-controlled study in subjects with pah who are currently receiving approved therapy for their pah (i.e., endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor)or as a monotherapy treatment. study visits will occur at 4 week intervals for 12 weeks with the key measure of efficacy being the 6-minute walk test. study procedures include routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. at the end of the first 12-weeks, the patient will be un-blinded. patients will continue with another 12-week open label portion with visits occuring at 4-week intervals. patients who complete all assessments for 24-weeks will also be eligible to enter a 36 month open-label, extension phase study (freedom - ext).

this study is an international, multi-center, randomized, double-blind, placebo-controlled study in subjects with pah who are currently receiving approved therapy for their pah (i.e., endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor)or as a monotherapy treatment. study visits will occur at 4 week intervals for 12 weeks with the key measure of efficacy being the 6-minute walk test. study procedures include routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. at the end of the first 12-weeks, the patient will be un-blinded. patients will continue with another 12-week open label portion with visits occuring at 4-week intervals. patients who complete all assessments for 24-weeks will also be eligible to enter a 36 month open-label, extension phase study (freedom - ext).

Eligibility criteria:
inclusion criteria: * between 18 and 70 years of age, inclusive * body weight at least 50 kilograms * pah that is either idiopathic/familial; associated with repaired congenital systemic-to-pulmonary shunts (repaired ≥ 5 years); associated with collagen vascular disease; associated with hiv. * currently receiving an approved endothelin receptor antagonist and/or an approved phosphodiesterase-5 inhibitor for at least 90 days and on a stable dose for at least the last 30 days or not currently receiving approved pah therapy. * previous testing (e.g., right heart catheterization, echocardiography) consistent with the diagnosis of pah. * reliable and cooperative with protocol requirements. exclusion criteria: * nursing or pregnant. * received a prostacyclin within the past 30 days. * pah due to conditions other than noted in the above inclusion criteria. * history of uncontrolled sleep apnea, renal insufficiency, anemia, left sided heart disease, uncontrolled systemic hypertension, or parenchymal lung disease. * use of an investigational drug within 30 days of baseline

Keywords: pulmonary arterial hypertension
core: capecitabine, oxaliplatin, radiotherapy and excision

Conditions: Rectal Neoplasms

Summary: primary objective: * pathological complete response (ypt0n0) rate secondary objectives: * histopathological r0 resection rate * pathological downstaging (ypt0-t2n0) rate * one month surgical complication rate * predictive value of pre-operative mri for surgical, pathological and clinical outcomes * safety * local and distant recurrence rates * progression-free survival * overall survival


Eligibility criteria:
* histologically proven adenocarcinoma of the rectum (tumour ≤ 12 cm from the anal verge) * no evidence of distant spread * no prior therapy for chemotherapy or radiation therapy for rectal cancer * patient considered locally advanced by mri: * tumour beyond mesorectal fascia, or * tumour ≤ 2mm from mesorectal fascia, or * t3 tumour \< 5cm from anal verge * for female patient of childbearing potential, neither pregnant nor breastfeeding, and under active contraception * no peripheral neuropathy \> grade1 * ecog ps ≤ 2 * anc \> 1,500 x 10\^9/l * platelets \> 100,000 x 10\^9/l * creatinine \< 1.5 x iuln * bilirubin \< 1.5 iuln * sgpt (alt) \< 2.5 iuln * no pre-existing condition which would deter chemoradiotherapy * no uncontrolled diarrhoea or fecal incontinence * no significant small bowel (\> 200cc or 6x6x6cm) delineated within the radiation fields * no other serious uncontrolled concomitant illness * informed consent signed the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
edema2: evaluation of dx-88's effect in mitigating angioedema

Conditions: Hereditary Angioedema (HAE)

Summary: edema2 is an open-label, phase 2 dose-ranging study designed to assess the safety and efficacy of repeated dosing of dx-88 (recombinant plasma kallikrein inhibitor) in patients with hereditary angioedema.


Eligibility criteria:
inclusion criteria: * 10 years of age or older * documented diagnosis of hae (type i or ii) * patient reported to a study site no later than 4 hours following patient recognition of the onset of the attack * willing and able to give informed consent exclusion criteria: * patients with a serious intercurrent illness or serious active infection * patient with serum creatinine greater than 110% the upper limit of normal or liver transaminases 2 times the upper limit of normal * receipt of an investigational drug or device, within 30 days prior to study treatment * pregnancy or breastfeeding * diagnosis of acquired angioedema (aae) * patients who had not completed their day-7 follow-up procedures for a previously treated attack
pregnancy and birth outcome in women with pompe disease

Conditions: Pompe Disease

Summary: this study explores the outcome and effect of pregnancy on pompe disease. the results are expected to guide clinicians in counseling and care of women with pompe disease, who are planning to become pregnant, and during the pregnancy.

pompe disease (glycogen storage disease type ii) is a lysosomal storage disorder resulting from the deficiency of the enzyme acid alpha-glucosidase. similar to many lysosomal storage diseases, the phenotypic spectrum in pompe disease is varied, existing in infantile, and late-onset forms. in the classic infantile form, patients develop cardiomyopathy, resulting in premature death. in the later-onset forms, there is proximal muscle weakness similar to that of limb-girdle muscular dystrophy, which is associated with progressive weakness of different muscle groups. the primary morbidity in pompe disease is associated with progressive respiratory insufficiency. events that act as metabolic stressors, in general, such as pregnancy may act as modifiers in lysosomal storage disorders. in much studied gaucher disease, pregnancy increased the risk of acute bone crises, even in otherwise asymptomatic patients. however, similar studies lack for pompe disease. most data that is used to counsel patients with pompe disease are derived from other muscular dystrophies, because obstetric risk and complications. this is a retrospective case review study in female subjects age 18years and above. this study investigates the effects of acid alpha-glucosidase deficiency on pregnancy, pregnancy and disease outcomes in patients with adult-onset pompe disease. the study will define the immediate effect of enzyme replacement therapy with lumizyme/myozyme on the outcomes of pregnancy and the fetus. subjects will be invited to participate through an initial mail or phone contact. if patient is interested, and agrees to participate in the study the study questionnaire will be provided to them. the patients then, need to complete the questionnaire, sign and date it and mail it back along with a release of any medical information forms. the returned signed and dated questionnaire from the patient serves as an indication of their consent to participate in the study. alternatively, study pi or coordinator may review the questionnaire with the subject during a phone interview. however, the subject's signature is still required to attest to participate in the study.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of pompe disease * females age 18 and over * have been pregnant or anticipating pregnancy in near future. exclusion criteria: * if the diagnosis of pompe disease is not confirmed * if the subject is not able to consent